Filenews 19 February 2021
Johnson & Johnson has applied to the European Medicines Agency (EMA) for a European conditional marketing authorisation for Janssen's research candidate vaccine against COVID-19.
In particular, Johnson & Johnson announced that Janssen-Cilag International N.V. has submitted to the European Medicines Agency (EMA) an application for a conditional marketing authorisation (CMAA) to obtain a licence for its single-dose vaccine against COVID-19.
The submission of the application is based on first-line efficacy and safety data from the Phase 3 ENSEMBLE clinical trial.
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years of age and older. The study was designed to assess the safety and efficacy of Janssen's research vaccine in protection against moderate and severe COVID-19 disease, with an evaluation of efficacy from day 14 and day 28 as co-primary endpoints.
The test, carried out in eight countries and three continents, involves a diverse and wide population.
"Across Europe, there is still an urgent need for more vaccines against COVID-19. The request submitted today is an important step forward because it ensures that the European Union has another choice, which will help reduce the impact that the pandemic has had on Europe and around the world," said Paul Stofels, M.D., Vice-President of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.
Once the conditional marketing authorisation has been issued, the company is obliged to fulfil specific obligations within specified timetables, one of which will be the provision of additional data.
Johnson & Johnson announced in December that it had begun the process of progressively evaluating EMA licensing for Janssen's research vaccine against COVID-19, a process that enables EMA to review the data as they become available. In addition, progressive evaluation procedures for the single-dose research vaccine against COVID-19 have been launched in numerous countries around the world, as well as by the World Health Organisation (WHO).
It is recalled that the company applied for Emergency Licensing (EUA) in the United States of America on 4 February 2021.
Source: protothema.gr
